Quality System Implementation for Early Stage Med Tech Companies

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Course Description:

The establishment of a Quality System is a requirement of all U.S. and International regulatory agencies for organizations that design and/or develop medical devices. An effective Quality System will save a Med Tech company time and money by helping to ensure that its final product meets customer and regulatory requirements (in other words that it does what it is expected to do).

This course will detail the components of a Quality System and discuss the reality of implementing of an effective Quality System in an early stage Med Tech company.

Presenter Bio:

Julie Jenks, M.S. has over ten years of experience in the biotechnology industry. She has worked in several positions contributing to the development of in vitro diagnostics and medical devices, most recently at Roche Molecular Systems in Pleasanton, CA. For the past two years she has been providing Quality Assurance consulting services for Medical Device companies in Northern California as the Sole Proprietor and lead Quality Assurance consultant for NorCal Quality Consulting.